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Side effects (drug)
A side effect or adverse effect of a treatment is an abnormal, harmful, undesired and/or unintended effect, although not necessarily unexpected, which is obtained as a result of a therapy or other medical intervention, such as drug/chemotherapy, physical therapy, surgery, medical procedure, use of a medical device, etc. Iatrogenesis (literally, generated by a physician) is a common cause of adverse effects, as well as medical error. Using a drug or other medical intervention which is contraindicated may increase the risk of side effects. Adverse effects may cause medical complications of a disease or procedure and negatively affect its prognosis. The harmful outcome is usually indicated by some result such as morbidity, mortality, alteration in body weight, levels of enzymes, loss of function or as a pathological change detected at the microscopic, macroscopic or physiological level. They may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods, or procedures (e.g. drug interaction). Reporting systems In many countries, adverse effects are required by law to be reported, researched in clinical trials and included into the patient information accompanying medical devices and drugs for sale to the public. Adverse effects of drugs Adverse effects can occur as a collateral or side effect of many interventions, but they are particularly important in pharmacology, due to its wider, and sometimes uncontrollable, use by way of self-medication. Thus, responsible drug use becomes an important issue here. Adverse effects, like intended effects of drugs, are a function of dosage or drug levels at the target organs, so they may be avoided or decreased by means of careful and precise pharmacodynamics (the change of drug levels in the organism in function of time after administration). Adverse effects may also be caused by drug interaction, i.e., when physicians fail to check for all medicaments a patient is taking and prescribe new ones which interact agonistically or antagonistically (potentiate or decrease the intended therapeutic effect). Significant morbidity and mortality is caused around the world because of this. Drug-drug and food-drug interactions may occur, and even so-called "natural drugs" used in alternative medicine may have dangerous adverse effects. For example, extracts of St. John's wort (Hypericum perforatum), a phytotherapic used for treating mild depression are known to cause an increase in the cytochrome P450 enzymes responsible for the metabolism and elimination of many drugs, so that patients taking it are likely to experience a reduction in blood levels of drugs that they are taking for other purposes, such as cancer chemotherapeutic drugs, protease inhibitors for HIV and oral contraceptives. The scientific field of activity associated with drug safety is increasingly government-regulated and is of major concern for the public as well as to drug manufacturers. The distinction between adverse and non-adverse effects is a major undertaking when a new drug is developed and tested before marketing it. This is done in toxicity studies to determine the non-adverse effect level (NOAEL). These studies are used to define the dosage to be used in human testing (phase I) as well as to calculate the maximum admissible daily intake. Imperfections in clinical trials, such as insufficient number of patients or short duration, sometimes lead to public health disasters such as those of fenfluramine (the so-called fen-phen episode), thalidomide and, more recently, of cerivastatin (Baycol®, Lipobay®) and rofecoxib (Vioxx®), where drastic adverse effects were observed, like teratogenesis, pulmonary hypertension, stroke, heart disease, neuropathy, etc., and a significant number of deaths, causing the forced or voluntary withdrawal of the drug from the market. Most drugs have a large list of non-severe or mild adverse effects which do not rule out the interruption of usage. These effects have widely variable incidence, according to individual sensitivity. They comprise nausea, dizziness, diarrhea, malaise, vomit, headache, dermatitis, dry mouth, etc. Examples of adverse effects Most drugs have a large list of non-severe or mild adverse effects which do not rule out the interruption of usage. These effects have widely variable incidence, according to individual sensitivity. They comprise nausea, dizziness, diarrhea, malaise, vomit, headache, dermatitis, , etc. Other side effects of interest to psychologists are: * Addiction and drug dependency eg with many sedatives and analgesics such as diazepam, morphine, etc. * Behavior problems as a side effect of drugs **Increased impulsive behavior as a side effects of drugs **Increased suicidal behavior as a side effects of drugs eg increased tendency associated to the use of fluoxetine and other SSRI antidepressants **Increased violent behavior as a side effects of drugs * Cognitive impairment as a side effects of drugs **Attention impairment as a side effects of drugs ****Concentration impairment as a side effects of drugs ****Vigilance impairment as a side effects of drugs **Executive function deficits as a side effects of drugs **Memory disorders as a side effects of drugs **Perceptual disorders as a side effects of drugs ***Auditory disturbances as a side effects of drugs ****Auditory hallucinations as a side effects of drugs ****Deafness as a side effects of drugs associated with gentamicin (an antibiotic) ***Olfactory disturbances as a side effects of drugs ***Visual disturbances as a side effects of drugs ****Colour blindness as a side effects of drugs ****Visual hallucinations as a side effects of drugs ***Thought disturbances as a side effects of drugs * Mood disturbance as a side effect of drugs ** Increased aggression ** Agitation as a side effects of drugs ** Apathy as a side effects of drugs ** Anxiety as a side effects of drugs ** Depression as a side effects of drugs caused by interferon ** Irritability as a side effects of drugs ** Nervousness as a side effects of drugs * Mental disorders as a side effect of drugs **Exacerbation of existing mental disorders as a side effect of drugs ** Psychosis as a side effect of drugs ** Mania as a side effects of drugs * Nervous system disorders as a side effects of drugs ** Akathisia as a side effects of drugs ** Motor skill deficits as a side effects of drugs ** Seizures as a side effects of drugs caused by withdrawal from benzodiazepine ** Speech difficulties as a side effects of drugs ** Tardive dyskinesia associated with long-term use of metoclopramide and many antipsychotic medications. * Neurological disorder as a side effect of drugs * Physiological side effect of drugs ** Appetite change as a side effect of drugs ***Increased appetite as a side effect of drugs ***Decreased appetite as a side effect of drugs ** Fatigue as a side effects of drugs ** Libido change as a side effect of drugs ***Increased libido as a side effect of drugs ***Decreased libido as a side effect of drugs ** Sleep disorders as a side effect of drugs *** Insomnia as side effect of drugs caused by stimulants, Ritalin®, Adderall®, etc. *** Sleepiness as side effect of drugs eg] due to some antihistamine use Physical side effects with psychological implications * Abortion, miscarriage and/or severe vaginal or uterine hemorrhage associated with misoprostol (Cytotec®), a labor-inducing drug (this is a case where the adverse effect has been used legally and illegally for performing abortions) * Arrythmias * Blood pressure and pulse changes * Constipation * Diabetes caused by atypical antipsychotic medications (neuroleptic psychiatric drugs) * Diarrhea caused by the use of orlistat (Xenical®) * Death, following sedation in children using propofol (Diprivan®) * Dementia * Difficulty breathing or ]swallowing * Dizziness * Drug allergies * Drug induced congenital disorders * Erectile dysfunction associated with many drugs, such as antidepressants * Fainting * Fever associated with vaccination (in the past, imperfectly manufactured vaccines, such as BCG and poliomyelitis, have caused the very disease they intended to fight). * Glaucoma associated with corticosteroid-based eye drops * Hair loss and anemia may be caused by chemotherapy against cancer, leukemia, etc. * Headache following spinal anesthesia * Hypertension in ephedrine users, which prompted FDA to remove the status of dietary supplement of ephedra extracts * Lactic acidosis associated with the use of stavudine (Zerit®, for anti-HIV therapy) or metformin (for diabetes) * Melasma and thrombosis associated with oral contraceptive use * Nausea * Neuroleptic malignant syndrome * Neuropathy * Pain - Chest pain, headache, joint pain], muscle pain, painful menstruation, stomach pain * Rhabdomyolysis associated with statins (anti-cholesterol drugs) * Stroke or heart attack associated with sildenafil (Viagra®) when used with nitroglycerine * Tics * Weight loss or weight gain Side effects by drug group *Adrenergic blocking drugs - side effects *Adrenergic drugs - side effects *Analeptic drugs - side effects *Analgesic drugs - side effects *Anesthetic drugs - side effects *Anti inflammatory drugs - side effects *Antiandrogens - side effects *Antibiotics - side effects *Anticoagulant drugs - side effects *Anticonvulsive drugs - side effects *Antidepressant drugs - side effects *Antiemetic drugs - side effects *Antiestrogens - side effects *Antihistaminic drugs - side effects *Antihypertensive drugs - side effects *Antineoplastic drugs - side effects *Antiarrhythmic drugs - side effects *Antispasmodic drugs - side effects *Antitremor drugs - side effects *Antitubercular drugs - side effects *Antiviral drugs - side effects *Appetite depressing drugs - side effects *Barbiturates - side effects *Benzodiazepines - side effects *Bromides - side effects *Cholinergic blocking drugs - side effects *Cholinergic drugs - side effects *Cholinesterase inhibitors - side effects *Cholinomimetic drugs - side effects *CNS affecting drugs - side effects *CNS depressant drugs - side effects *CNS stimulating drugs - side effects *Corticosteroids - side effects *Diuretics - side effects *Dopamine agonists - side effects *Emetic drugs - side effects *Ganglion blocking drugs - side effects *Hallucinogenic drugs - side effects *Heart rate effecting drugs - side effects *Hypnotic drugs - side effects *Muscle relaxing drugs - side effects *Narcotic agonists - side effects *Narcotic antagonists - side effects *Narcotic drugs - side effects *Neuromuscular-blocking drug - side effects *Neuroleptic drugs - side effects *Nootropic drugs - side effects *Psychotomimetic drugs - side effects *Respiration stimulating drugs - side effects *Sedatives - side effects *Serotonin agonists - side effects *Serotonin antagonists - side effects *Steroids - side effects *Sympatholytic drugs - side effects *Sympathomimetic drugs - side effects *Tricyclic antidepressant drugs - side effects *Tranquilizing drugs - side effects *Vasoconstrictor drugs - side effects *Vasodilator drugs - side effects Controversies Sometimes, putative medical adverse effects are regarded as controversial and generate heated discussions in society and lawsuits against drug manufacturers. One example is the current controversy whether autism may be caused by the MMR vaccine (or by thimerosal, a mercury-based preservative used in some vaccines). No significative link has been found so far, but this has not prevented lawsuits. Due to the exceedingly high impact on public health of widely used medications, such as oral contraceptives and hormone replacement therapy, which may affect millions of users, even marginal probabilities of adverse effects of a severe nature, such as breast cancer, have led to public outcry and changes in medical therapy, although its benefits largely surpassed the statistical risks. See also * Biosafety * Contraindication * Complication (medicine) * Dirty drug * Drug interaction * Drug sensitivity * Drug tolerance * Evidence-based medicine * Iatrogenesis * List of withdrawn drugs * Medical algorithm * Medical error * Medical prescription * Medication induced movement disorders * Side effects (treatment) * Toxicology External links * Patient Safety Network. An extremely useful site, with a glossary and articles on all kinds of threats to patient safety, including adverse effects, drug reactions, medical error, iatrogenesis, etc. * ADRD.org - Searchable Database of Adverse Drug Reactions (ADRs) * Australian Adverse Drug Reactions Bulletin - published bimonthly by ADRAC * Drugs of Concern DrugIntel.com site for tort lawyers with up-to-date information on drugs that cause severe adverse effects) * Medication Errors a FDA site. * Medical Product Safety Information. MedWatch, an useful page from FDA, listing safety alerts for drugs, biologics, devices and dietary supplements, recalls, market withdrawals, public health advisories, links to the VAERS and MAUDE databases, etc.) * Medical Devices Safety National Library of Medicine (Medline Plus, useful lists of conventional drug and medical device articles and websites) Category:Medical terms Category:Medical ethics Category:Medical treatments Category:Pharmacology Category:Side effects (drug) Category:Side effects (treatment)